Dysautonomia International

Breast Mesh Used in Two-staged Breast Reconstruction

Purpose

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Conditions

Breast Cancer
Radiation
Breast Reconstruction
Synthetic Mesh

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

Diagnosed with breast cancer 2. More than 18 years old 3. Karnofsky Performance Status (KPS) larger than 80 4. No clinical or imaging evidence of distant metastasis 5. BMI < 35kg/m2 6. Patients with no or mild breast ptosis 7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. 8. Mental Health Patient -

Exclusion Criteria

Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion -

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Breast Reconstruction with breast mesh	The tissue expander-implant reconstruction with TiLoop Bra mesh.	Procedure: TiLoop Bra mesh in expander-implant breast reconstrution The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
Active Comparator Breast Reconstruction without breast mesh	The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.	Procedure: sub-pectoral expander-implant breast reconstruction The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Recruiting Locations

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Contact:
Edward Chang

More Details

Status: Recruiting
Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study Contact

Jian Yin
+86-22-23340123
yinjian@tjmuch.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.